Label: OVERTIME- methyl salicylate, menthol and capsaicin lotion

  • NDC Code(s): 27495-008-02, 27495-008-04
  • Packager: Physicians Science & Nature Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 20, 2021

If you are a consumer or patient please visit this version.

  • Active Ingredients

    Methyl Salicylate 30%

    Capsaicin 0.0375%

    Menthol USP 10%

  • Purpose

    Topical Analgesic

  • USES:

    For temporary relief of minor aches and pain of muscles and joints associated with arthritis, simple backache, sprains, and strains. Does not cure any disease.

  • WARNINGS:

    For external use only
    Avoid contact with eyes, mouth, mucous membranes, or genitals
    Do not tightly bandage
    Ask a physician before use if pregnant, nursing or taking anticoagulant medication.
  • Keep away from children

  • DIRECTIONS:

    Use only as directed. Shake before each use. Prior to first use, rub small amount to check for sensitivity. Gently rub over painful areas no more than 4 times daily. Dry before contact with clothes or bedding to avoid staining. Wash hands after use. If swallowed, call Poison Control. If placed into eyes, rinse with cold water and call a physician. Store below 90°F/32°C.

  • Do Not Use:

    On wounds, irritated or damaged skin
    In excessive amounts
    With a heating pad
    With other topical pain products
    On children under 12 years old
    If allergic to ingredients listed or aspirin products.
  • Stop Use and Ask a Physician:

    For severe undiagnosed pain
    If pain worsens or persist for more than 7 days
    If pain clears up and then recurs in a few days
    If itching or rash occurs.
  • INACTIVE INGREDIENTS:

    water, glyceryl stearate, PEG 100 stearate, stearic acid, propylene glycol, cetyl alcohol, dimethyl isosorbide, poloxamer 407, aloe, barbadensis gel, borage oil, copolymer, zingiber officinale root extract, boswellia serrata extract, soya lecithin, methylparaben, propylparaben, DMDM hydantoin, sodium stearoyl glutamate, triethanolamine.

  • SPL UNCLASSIFIED SECTION

    Manufactured for Physician's Science and Nature Inc.
    220 Newport Center Drive 11-634, Newport Beach, CA 92660
    For information, or to place a new order visit:
    www.overtimepainrelief.com or call (888) 441-6680

    Made in the USA
    Patent Pending

  • Principal Display Panel - 2 oz

    PHYSICIAN'S SCIENCE AND NATURE, INC.

    OVERTIME®
    PAIN RELIEF LOTION

    Deep Penetrating Action
    CLINICALLY TESTED

    2 oz (60 ml)
    NDC 27495-008-02

    Principal Display Panel - 2 oz Label

    2 oz Label

  • INGREDIENTS AND APPEARANCE
    OVERTIME 
    methyl salicylate, menthol and capsaicin lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27495-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE18 g  in 60 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL6 g  in 60 mL
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.0225 g  in 60 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BORAGE SEED OIL (UNII: F8XAG1755S)  
    GINGER (UNII: C5529G5JPQ)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:27495-008-0250 in 1 CARTON01/01/2007
    160 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:27495-008-0450 in 1 CARTON01/01/2007
    2120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/01/2007
    Labeler - Physicians Science & Nature Inc. (012485755)